Fast home COVID-19 tests are fast, but the regulatory approval needed to get them into the hands of Americans is coming slowly.
Why it matters: Rapid, fully at-home COVID-19 testing can make a significant contribution to halting the pandemic – and opening a new frontier for more constant disease surveillance – but old assumptions about how diagnostics should be used hold it back.
Send the news: The Biden government on Wednesday unveiled a $ 1.6 billion plan to speed up COVID-19 testing in schools and other institutions, strengthen material testing supply chains and improve genetic sequencing.
- “We still do not have enough tests, and we do not have enough tests in all the places where it should be,” Cariden Coordinator Cariden Johnson told reporters.
By the numbers: The number of COVID-19 tests performed in the US per day has dropped by about 30% from the peak a month ago.
- The U.S. conducted a total of about 340 million tests – just over one per person during the nearly year-long pandemic.
Some of the dip is probably due to declining case numbers. But for proponents of fast-paced home tests, the drop also indicates problems in using tests – and the kind of tests that have been approved.
- COVID-19 tests are mostly used to diagnose people who are sick, and most approved tests use very accurate but often labor-intensive PCR methods that require people to travel to clinics.
- The logistics and cost of manufacturing and operating PCR tests make it difficult to continually survey the population – this is exactly how cheaper, fast COVID-19 tests can be used.
Context: Pasadena, California, Innova produces COVID-19 tests that cost less than $ 5 and work easily with a home pregnancy test, which delivers results within 15-30 minutes.
- For months, Innova has been sending millions of these tests to the UK, where they are being used as part of Prime Minister Boris Johnson’s moonshot “mass testing program. Innova CEO Daniel Elliott says the company can currently make 15 million test kits a day, with plans to expand to 50 million a day by the summer.
- But the rapid trial of Innova – which was first submitted to the FDA for approval in August – has not yet received the emergency permit for emergency use (EUA) required for wide distribution, a status it shares with many other rapid tests that are at home, such as one that has been developed. by Gauss and Cellex who use a smartphone to interpret results.
- “The FDA was a bit of a challenge,” Elliott says. “We’m used to looking at tests that we should be almost laboratory grade, and there just is not that much experience in some kind of test of this broad that is useful for different purposes.”
How it works: Rapid tests like Innova’s search for a specific viral protein called an antigen.
- Antigen tests are less accurate than PCR. A study by Innova found that the test correctly identified 78.8% of cases in a group of 198 samples compared to PCR results in laboratory areas, a lower rate that can cause more false positive and negative results .
- But proponents of rapid testing say the tests are particularly good at identifying people who are in the contagious state of their disease.
- That, combined with their excellent ability to regularly test large numbers of people, they make it a “public health tool to suppress outbreaks,” according to Michael Mina, an epidemiologist at the Harvard TH Chan School of Public Health.
What they say: “We consider home use testing a top priority,” Jeffrey Shuren, a top FDA official who oversees the testing, told The Hill recently. “And if they have their data and the data looks good, we may approve it.”
- The FDA recently approved an EUA for a full home test manufactured by Ellume, with very accurate results, but with a potential price of $ 30 or less, it will cost more to scale.
The other side: Some experts, also from the UK, where trigger testing is more widely distributed, are concerned that ordinary people will misread the tests and further erode their accuracy and that it will give them a false sense of security.
- But similar fears that arose when home pregnancy tests were first made available have never materialized, and advocates believe that rapid screening could be used to use this technology for other home tests in the future, according to CEO Siddarth Satish. van Gauss.
The conclusion: The US healthcare system is set up to deliver the highest quality care – often at equally high prices – but COVID-19 testing is one area where fast and cheap can be the right approach in a real emergency.